J Clin Transl Hepatol. 2013 Sep;1(1):59-74. doi: 10.14218/JCTH.2013.D002X. Epub 2013 Sep 15.
Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis?.
Journal of clinical and translational hepatology
Rolf Teschke, Axel Eickhoff, Johannes Schulze
Affiliations
Affiliations
- Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/ Main, Germany.
- Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.
PMID: 26357608
PMCID: PMC4521275 DOI: 10.14218/JCTH.2013.D002X
Abstract
Drug-induced liver injury (DILI) and herb-induced liver injury (HILI) are typical diseases of clinical and translational hepatology. Their diagnosis is complex and requires an experienced clinician to translate basic science into clinical judgment and identify a valid causality algorithm. To prospectively assess causality starting on the day DILI or HILI is suspected, the best approach for physicians is to use the Council for International Organizations of Medical Sciences (CIOMS) scale in its original or preferably its updated version. The CIOMS scale is validated, liver-specific, structured, and quantitative, providing final causality grades based on scores of specific items for individual patients. These items include latency period, decline in liver values after treatment cessation, risk factors, co-medication, alternative diagnoses, hepatotoxicity track record of the suspected product, and unintentional re-exposure. Provided causality is established as probable or highly probable, data of the CIOMS scale with all individual items, a short clinical report, and complete raw data should be transmitted to the regulatory agencies, manufacturers, expert panels, and possibly to the scientific community for further refinement of the causality evaluation in a setting of retrospective expert opinion. Good-quality case data combined with thorough CIOMS-based assessment as a standardized approach should avert subsequent necessity for other complex causality assessment methods that may have inter-rater problems because of poor-quality data. In the future, the CIOMS scale will continue to be the preferred tool to assess causality of DILI and HILI cases and should be used consistently, both prospectively by physicians, and retrospectively for subsequent expert opinion if needed. For comparability and international harmonization, all parties assessing causality in DILI and HILI cases should attempt this standardized approach using the updated CIOMS scale.
Keywords: Causality assessment; Drug hepatotoxicity; Drug-induced liver injury; Herb-induced liver injury; Herbal hepatotoxicity
References
- Gastroenterology. 2011 Nov;141(5):1665-72.e1-9 - PubMed
- Regul Toxicol Pharmacol. 2011 Feb;59(1):1-7 - PubMed
- Ann Hepatol. 2012 Jul-Aug;11(4):544-9 - PubMed
- J Hepatol. 2000 Dec;33(6):1003-5 - PubMed
- Phytomedicine. 2009 Jan;16(1):72-84 - PubMed
- Aliment Pharmacol Ther. 2008 May;27(9):780-9 - PubMed
- Menopause. 2009 Sep-Oct;16(5):956-65 - PubMed
- Regul Toxicol Pharmacol. 2012 Jun;63(1):1-9 - PubMed
- Ann Hepatol. 2009 Jul-Sep;8(3):258-66 - PubMed
- J Hepatol. 2000 Dec;33(6):949-52 - PubMed
- Clin Pharmacol Ther. 2011 Jun;89(6):806-15 - PubMed
- Clin Toxicol (Phila). 2011 Jan;49(1):34-9 - PubMed
- Hepatology. 2010 Jun;51(6):2117-26 - PubMed
- Aliment Pharmacol Ther. 2013 Jan;37(1):3-17 - PubMed
- J Clin Epidemiol. 1993 Nov;46(11):1331-6 - PubMed
- Expert Opin Drug Metab Toxicol. 2009 Aug;5(8):843-60 - PubMed
- J Clin Pharm Ther. 2003 Apr;28(2):137-43 - PubMed
- Gastroenterol Clin Biol. 1987 Aug-Sep;11(8-9):581-5 - PubMed
- BMJ. 1999 Dec 11;319(7224):1541 - PubMed
- Eur J Gastroenterol Hepatol. 2013 Sep;25(9):1093-8 - PubMed
- Eur J Gastroenterol Hepatol. 2012 Mar;24(3):270-80 - PubMed
- Hepatol Res. 2003 Nov;27(3):192-195 - PubMed
- World J Hepatol. 2013 Jul 27;5(7):353-63 - PubMed
- J Clin Pharm Ther. 2010 Oct;35(5):545-63 - PubMed
- Drug Saf. 2008;31(1):21-37 - PubMed
- Pharmacoepidemiol Drug Saf. 2011 Oct;20(10 ):1080-7 - PubMed
- Gut. 1999 May;44(5):731-5 - PubMed
- Hepatology. 2001 Jan;33(1):308-10 - PubMed
- Clin Pharmacol Ther. 1977 Mar;21(3):247-54 - PubMed
- J Hepatol. 1988 Aug;7(1):132-6 - PubMed
- Gastroenterology. 2008 Dec;135(6):1924-34, 1934.e1-4 - PubMed
- Clin Pharmacol Ther. 1981 Aug;30(2):239-45 - PubMed
- Drug Saf. 2009;32(1):55-68 - PubMed
- World J Gastroenterol. 2008 Nov 28;14 (44):6774-85 - PubMed
- Ann Hepatol. 2012 Jul-Aug;11(4):564-9 - PubMed
- Ann Hepatol. 2012 Jul-Aug;11(4):500-12 - PubMed
- Gastroenterology. 2005 Aug;129(2):512-21 - PubMed
- Regul Toxicol Pharmacol. 2011 Dec;61(3):282-91 - PubMed
- Hepatology. 2001 Jan;33(1):123-30 - PubMed
- Rev Esp Enferm Dig. 2008 Nov;100(11):688-95 - PubMed
- World J Gastroenterol. 2013 May 21;19(19):2864-82 - PubMed
- Therapie. 1985 Mar-Apr;40(2):111-8 - PubMed
- Expert Opin Drug Saf. 2013 May;12 (3):339-66 - PubMed
- J Hepatol. 1990 Sep;11(2):272-6 - PubMed
- Am J Gastroenterol. 2010 Jul;105(7):1561-6 - PubMed
- Hepatol Res. 2004 Nov;30(3):148-154 - PubMed
- Regul Toxicol Pharmacol. 2012 Nov;64(2):342; author reply 343-4 - PubMed
- Pharmacoepidemiol Drug Saf. 2011 Jun;20(6):567-82 - PubMed
- Ann Hepatol. 2013 Jan-Feb;12 (1):11-21 - PubMed
- Clin Gastroenterol Hepatol. 2010 May;8(5):463-70 - PubMed
- Br J Clin Pharmacol. 2008 Dec;66(6):758-66 - PubMed
- J Hepatol. 2011 Sep;55(3):683-91 - PubMed
- Drug Saf. 2012 Dec 1;35(12 ):1091-7 - PubMed
- Hepatology. 1997 Sep;26(3):664-9 - PubMed
- Hepatology. 2008 Oct;48(4):1175-83 - PubMed
- J Clin Epidemiol. 1993 Nov;46(11):1323-30 - PubMed
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